Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAstraZeneca
About this trial
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
16 years old in Module 1 (US only: ≥18year)
12 years old in Module 2
Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts > 5% or reappearance of blasts in PB)
Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
Disqualifiers
Burkitt lymphoma and leukemia
Isolated extramedullary disease; Active testicular or CNS (> CNS1) involvement
Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Trial design
Design model
Sequential
Treatments tested in this trial
AZD4512 monotherapy
Combination productPatients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22
Treatment groups
83 Participants
are divided into 2 treatment groupsGroup A: Module 1 Dose EscalationExperimental treatment 1 intervention
Group B: Module 2 Dose OptimizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).
DLTs are dose-limiting toxicities as defined in the study protocol.
Time frame
From first dose up to 21 days (DLT period).2
Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)
Assessed by the CTCAE criteria version 5.0
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)3
Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)4
Module 1 (Dose Escalation): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)Secondary outcomes
1
Module 1 (Dose Escalation): Plasma PK parameters of AZD4512
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)2
Module 1 (Dose Escalation): Total antibody and total unconjugated payload
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)3
Module 1 (Dose Escalation): Area Under Curve (AUC)
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)4
Module 1 (Dose Escalation): Peak Plasma Concentration (Cmax)
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
Time frame
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
Fortrea
Collaborator
Source ClinicalTrials.gov